Implantica Receives FDA Approval for RefluxStop® in the U.S.

Implantica AG has secured Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its RefluxStop® implant-based treatment for gastroesophageal reflux disease (GERD). This approval grants the company access to the U.S. market, the largest medical device market globally.

The FDA's approval is based on several years of clinical development and rigorous review, demonstrating the five-year safety and effectiveness of the RefluxStop® therapy. The device is designed to address the root cause of acid reflux by restoring the natural anatomy of the gastroesophageal junction without encircling or compressing the food passageway.

"FDA approval of RefluxStop® is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review," stated Dr. Peter Forsell, CEO and founder of Implantica. "Most importantly, it means we can now bring RefluxStop® to the United States, where an estimated 78 million people suffer from acid reflux."

The company will commence its U.S. commercial launch with a targeted approach, focusing on select leading centers and reflux surgeons. RefluxStop® already has several years of commercial experience in Europe, with nearly 1,800 patients treated and over 60 Centers of Excellence established across nine European countries. Implantica anticipates that commercial adoption will build gradually as physician training and site activation progress.